Back to resultsPlatelet Rich Fibrin(PRF) Injection for Treatment of Dental Pulp Exposure:Randomized Clinical Trial
Primary Purpose
Dental Pulp Exposure, Dental Caries
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRF pulp capping
MTA pulp capping
Sponsored by
About this trial
This is an interventional treatment trial for Dental Pulp Exposure
Eligibility Criteria
Inclusion Criteria:
- deep carious lesion- no sign of irreversible pulpitis
Exclusion Criteria:
- old age- periapical lesion-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PRF
MTA
Arm Description
Outcomes
Primary Outcome Measures
pulp vitality
no sign of irreversible pulpitis or pulpal necrosis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04330768
Brief Title
Platelet Rich Fibrin(PRF) Injection for Treatment of Dental Pulp Exposure:Randomized Clinical Trial
Official Title
Platelet Rich Fibrin(PRF) Versus Pulp Capping in Treatment of Dental Pulp Exposure:Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
platelet rich fibrin(PRF) obtained from patient from patient blood sample (before start of treatment)is injected in the site of exposure of exposure(intervention group) control group will receive normal pulp capping procedure by MTA follow up will be one year
Detailed Description
intervention group:patient with deep caries lesion ,free from sign and symptoms of irreversible pulpitis the blood sample will be taken before the beginning of dental treatment..PRF will be obtained by blood centrifugal and injected in the site of exposure covered by glass ionomer restoration control group: patient with same condition will receive pulp capping procedure by MTA followed by glass ionomer restoration
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pulp Exposure, Dental Caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRF
Arm Type
Experimental
Arm Title
MTA
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
PRF pulp capping
Intervention Description
PRF is injected in the site of exposure
Intervention Type
Procedure
Intervention Name(s)
MTA pulp capping
Intervention Description
conventional pulp capping procedure
Primary Outcome Measure Information:
Title
pulp vitality
Description
no sign of irreversible pulpitis or pulpal necrosis
Time Frame
After 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
deep carious lesion- no sign of irreversible pulpitis
Exclusion Criteria:
old age- periapical lesion-
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Platelet Rich Fibrin(PRF) Injection for Treatment of Dental Pulp Exposure:Randomized Clinical Trial
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